Targeted radiation zaps glioblastoma cells after surgery
NCT ID NCT05533242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment for glioblastoma, an aggressive brain cancer. After standard therapy (surgery, chemo, radiation), a radioactive antibody is injected into the brain cavity to target remaining tumor cells and delay recurrence. The study enrolls 15 adults and focuses on finding the safest dose and measuring how radiation spreads in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Written patient consent after comprehensive information * Age between 18 and 80 years * Primary supratentorial high grade glioma after standard therapy (fluorescence-guided surgery, radio-chemotherapy, concomitant + adjuvant chemotherapy), with no or stable small tumor residue (residual contrast enhancement of up to 5cm3) at earliest 6 weeks after completion of radiotherapy * Histological verification of glioblastoma and CA 12-expression of tumor cells confirmed * Karnofsky-score ≥ 60 * Volume of resection cavity 2,5-25 cm3 * Male and female patients with reproductive potential must use an approved contraceptive method * Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start * Adequate bone marrow reserve: white blood cell (WBC) count ≥3000/μl, granulocyte count \>1500/μl, platelets ≥100000/μl, hemoglobin ≥ 10 g/dl * Adequate liver function: bilirubin \< 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) \< 3 times ULN. In the case of documented or suspected Gilbert's disease bilirubin \< 3 times ULN. * Blood clotting: INR (=PT) and PTT within acceptable limits according to the investigator * Adequate renal function: creatinine \< 3 times above ULN; eGFR \> (or equal) 60 ml/min Exclusion Criteria: * Patient unable to undergo imaging by CT, PET or contrast-enhanced MRI for whatever reason (i.e., pacemaker) * Resection cavity with intraventricular access * Significant leakage of radioactivity into CSF spaces or ventricles * Other actively treated invasive malignancy * Breastfeeding women * Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation, pre-existing neurological diseases except those related to glioblastoma or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Any active infection (at the discretion of the investigator) * Previous participation in a registered clinical trial with therapeutic intervention less than 6 weeks prior to enrolment (date of informed consent) * Allergy against known constituents of study medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinik für Allgemeine Neurochirurgie des Universitätsklinikums Köln
Cologne, 50937, Germany
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Klinik für Neurochirurgie des Universitätsklinikums Essen
Essen, 45147, Germany
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Klinik für Nuklearmedizin der Universität Münster
Münster, 48149, Germany
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Klinik für Nuklearmedizin des Universitätsklinikums Köln
Cologne, 50937, Germany
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Klinik für Nuklearmedizin, Strahlenklinik des Universitätsklinikums Essen
Essen, 45147, Germany
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Universitätsklinikum Würzburg - Neurochirurgie
Würzburg, 97080, Germany
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Universitätsklinikum Würzburg - Nuklearmedizin
Würzburg, 97080, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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